Cleared Traditional

ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER

K972595 · Avid N.I.T., Inc. · Anesthesiology
May 1998
Decision
313d
Days
Class 2
Risk

About This 510(k) Submission

K972595 is an FDA 510(k) clearance for the ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Avid N.I.T., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on May 20, 1998, 313 days after receiving the submission on July 11, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K972595 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1997
Decision Date May 20, 1998
Days to Decision 313 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

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